Modest FDA approvals promised for 2003

Washington Insider

The FDA promises a modest two-week improvement in mean approval times for new drugs (13.5 months instead of 14 months now), and a 30 percent increase in inspections at drug companies under President Bush's FY 2003 budget request, according to a press briefing in February

by acting associate FDA commissioner for management Jeff Weber. He said that total NDAs reviewed by the FDA are expected to rise from 190 in FY 2002 to 210 in FY 2003, with an increase from 80 to 88 in the number of NDAs expected to receive agency approval. Approvals for generic abbreviated new drug applications (ANDAs) are expected to rise from 256 in FY 2002 to 268 in FY 2003, but with a reduction in review time to 18 months - a reduction of one month over current experience. Medical device reviews are projected to stay flat under Bush's budget proposal.

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